NCT05707156

Brief Summary

Corticosteroids exposure is a common risk factor for invasive fungal infections. Systemic corticosteroid therapy treats several medical conditions, including rejection in solid organ transplant recipients, malignancy, and autoimmune or inflammatory diseases. Corticosteroid exposure is a well-known risk factor for developing PJP. Still, it remains unclear how prior corticosteroid exposure influences the presentation, severity, and mortality of opportunistic fungal infections. The investigators aim to prospectively characterize the corticosteroid use as a dose response to inform risk of invasive fungal infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,032

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

January 20, 2023

Last Update Submit

March 27, 2025

Conditions

Pneumocystis Jirovecii InfectionPneumocystisCryptococcosisCandidiasisAspergillosis

Keywords

ImmunocompetentCorticosteroidsPneumocystis cariniiPneumocystis jiroveciimortalityHIV-negative patients

Outcome Measures

Primary Outcomes (4)

  • PJP

    Number of cases of Pneumocystis jirovecii pneumonia

    3-6 months after first corticosteroid use

  • Cryptococcosis

    Number of cases of cryptococcosis

    3-6 months after first corticosteroid use

  • Aspergillosis

    Number of cases of Aspergillosis

    3-6 months after first corticosteroid use

  • Candidiasis

    Number of cases of Candidiasis

    3-6 months after first corticosteroid use

Secondary Outcomes (2)

  • Mortality

    3-6 months after first corticosteroid use

  • Hospitalization

    3-6 months after first corticosteroid use

Study Arms (3)

Low dose

Cumulative dose of corticosteroids 0-10 mg a day (prednisone equivalent) Prednisone: 0-10 mg OR, Dexamethasone: 0-1.5 mg OR, Prednisolone: 0-10 mg OR, Methylprednisolone: 0-8 mg

Medium dose

Cumulative dose of corticosteroids 10-20 mg a day (prednisone equivalent): Prednisone: 11-20 mg OR, Dexamethasone: 1.6-3.0 mg OR, Prednisolone: 11-20 mg OR, Methylprednisolone: 9-16 mg

High dose

Cumulative dose of corticosteroid \>20 mg a day (prednisone equivalent): Prednisone: \> 20 mg OR, Dexamethasone: \> 3.0 mg OR, Prednisolone: \> 20 mg OR, Methylprednisolone: \>16 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids

You may qualify if:

  • Patients on systemic corticosteroids for more than 2 weeks

You may not qualify if:

  • HIV infection
  • Transplant status
  • Younger than 18 years of age
  • Previous history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TrinetX based global network

Denver, Colorado, 80045, United States

Location

Related Publications (3)

  • Mundo W, Morales-Shnaider L, Tewahade S, Wagner E, Archuleta S, Bandali M, Chadalawada S, Johnson SC, Franco-Paredes C, Shapiro L, Henao-Martinez AF. Lower Mortality Associated With Adjuvant Corticosteroid Therapy in Non-HIV-Infected Patients With Pneumocystis jirovecii Pneumonia: A Single-Institution Retrospective US Cohort Study. Open Forum Infect Dis. 2020 Aug 13;7(9):ofaa354. doi: 10.1093/ofid/ofaa354. eCollection 2020 Sep.

    PMID: 33005696RESULT

  • Gharamti AA, Mundo W, Chastain DB, Franco-Paredes C, Henao-Martinez AF, Shapiro L. Pneumocystis jirovecii pneumonia: a proposed novel model of corticosteroid benefit. Ther Adv Infect Dis. 2021 Jul 20;8:20499361211032034. doi: 10.1177/20499361211032034. eCollection 2021 Jan-Dec. No abstract available.

    PMID: 34349985RESULT

  • Chastain DB, Kung VM, Golpayegany S, Jackson BT, Franco-Paredes C, Vargas Barahona L, Thompson GR 3rd, Henao-Martinez AF. Cryptococcosis among hospitalised patients with COVID-19: A multicentre research network study. Mycoses. 2022 Aug;65(8):815-823. doi: 10.1111/myc.13476. Epub 2022 Jun 19.

    PMID: 35657109RESULT

MeSH Terms

Conditions

Pneumocystis InfectionsPneumonia, PneumocystisCryptococcosisCandidiasisAspergillosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract Diseases

Study Officials

  • ANDRES F HENAO, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

July 5, 2023

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Not available, not applicable

Locations

US(1)